New Delhi: The Supreme Court may stop clinical trials in the country unless the health ministry provides it information within a month on deaths, compensation and general practices when new drugs are tested on Indians.
“We can even issue a one-line direction that all these clinical trials which affect many people must stop forthwith,” judges R.M. Lodha and A.R. Dave said on Monday.
In an unprecedented move, the apex court made all state governments and union territories parties to a public interest litigation, directing them to submit information on clinical trials in their jurisdictions.
The Union health ministry and Central Drugs Standards Control Organization have four weeks to furnish data and the provincial authorities have eight weeks to comply.
The court was hearing a lawsuit filed by non-profit Swasthya Adhikar Manch (SAM) in February 2012, which alleges wide abuse of people who participated in clinical trials in Madhya Pradesh by many international drug companies.
The court is taking the matter “very seriously”, the judges told additional solicitor general Siddharth Luthra, PTI reported.
The petitioner had moved interim applications seeking information on experimental drugs being tested in India, between January 2005 and 30th June 2012. Nearly 217 clinical trials of new chemical entities not approved as drugs for human use anywhere in the world are currently underway in various states across the country, the petitioner said.
“We have moved two interim applications till date on new chemical entities or experimental drugs introduced in India since January 2012. While it is not a complete list, we provide a list of drugs which are being tested but have no use for Indian patients,” said Amulya Nidhi, an health activist at SAM.
Further, the petitioner has also submitted data on multinational companies outsourcing clinical trials to India but getting marketing approvals in their countries, Nidhi said. “In absence of clear-cut laws, state governments have been hiding behind excuses about the issue being a subject of central governance.”
This is the first time that comprehensive data on clinical trials across the country will be put into the public domain, according to Chinmay Mishra, one of the petitioners. As per conservative estimates, there have been 2,374 reported deaths during clinical trials since 2007.
Monday’s order is the latest development in a string of official action in response to growing concerns on how clinical trials are conducted in India in the past year.
“This is great, because clinical trials aren’t just happening in Madhya Pradesh. They are also happening in Maharashtra, Tamil Nadu and other states, so it’s very important that other states are included as parties as well,” said Jayshree Sappute, a lawyer with non-profit Human Rights Law Network. “This is a very positive development.”
Since the country introduced patent protection laws in 2005, India has become a global hub for clinical trials, drawing companies because of its ethnically diverse pool of potential test subjects, while bringing down research and development costs by nearly 60%. PTI contributed to this report